Avec plus de 45'000 consultants dans le monde et générant un chiffre d’affaires d'EUR. 2.9 Mia, le Groupe Altran est le leader mondial dans les services d’ingénierie et de R&D (ER&D).
En Suisse, Altran emploie plus de 250 consultants et vise une forte croissance avec des bureaux à Zurich, Bâle, Lausanne et Genève.
Altran déploie son expertise notamment dans les secteurs suivants :
Sciences de la vie (Pharma, Biotech, et Dispositifs médicaux),
Industrie, Aéronautique, Automobile, Energie, Transports Ferroviaire,
Services financiers : Assurance des personnes et des biens, Assurance maladie, Réassurance, Banque
Titre du poste Design Quality Engineer
Numéro de référence 16892
Lieu de travail Suisse / CHE - Toutes régions /
Type de contrat CDD Temps Complet
Nombre minimum d’années d’expérience requis 5 ans d'expérience et plus
A permanent contract with the leader in innovation and high-tech engineering consulting
A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR.
2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).
In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
For our client, a multinational healthcare company, we are currently looking for a Design Quality Engineer, to start ASAP for a temporary contract located in Zuchwil, Switzerland.
Duties and Responsibilities :
Design Quality team member focused on life cycle management activities.
Enhance the Design Control and Risk Management processes to better reflect state of the art practices and drive continuous improvement.
Apply statistical methods and process / design excellence tools to establish test plans as well as evaluate test data and processes.
Perform Gage R&R studies.
Conduct and lead design verification and validation activities.
Conduct and lead design / process failure mode effects and analysis.
Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions (CAPA), Complaints, Nonconforming Materials, Risk Management, etc.
Provide leadership in the understanding of medical device regulations to other disciplines.
Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
Know and follow all laws and policies that apply to the job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Accountable for the successful delivery of multiple simultaneous projects, spanning multiple functional areas and locations.
Responsible of clear definition of project scope and deliverables, milestones and timeline, project risks and contingency plans.
A minimum of a Bachelor’s degree in Engineering or related technical or scientific discipline with a minimum of 7+ years of experience in related field is required.
Proven exceptional written and oral presentation skills
Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93 / 42 / EEC, ISO13485 and ISO14971 quality requirements is required.
Previous Quality Engineering experience is preferred.
Experience in an Medical Device regulated environment
Strong quality engineering skills with a proven track record in design verification / validation, process verification / validation, and design / process Failure Mode and Effects Analysis is preferred.
Fluency in English is required, good knowledge of German would be a strong asset.